Drug adverse event reports (FAERS)

Ovarian cancer

Drugs: BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM

SeriousOther seriousReport 27325204
Safetyreportversion
1
Safetyreportid
27325204
Primarysourcecountry
US
Occurcountry
US
Transmissiondateformat
102
Transmissiondate
20261010
Reporttype
2
Serious
1
Seriousnessdeath
2
Seriousnesslifethreatening
2
Seriousnesshospitalization
2
Seriousnessdisabling
2
Seriousnesscongenitalanomali
2
Seriousnessother
1
Receivedateformat
102
Receivedate
20260930
Receiptdateformat
102
Receiptdate
20260930
Fulfillexpeditecriteria
1
Companynumb
US-AstraZeneca-CH-01210963A
Primarysource
Reportercountry
US
Qualification
5
Sender
Sendertype
6
Senderorganization
ALEXION PHARMACEUTICALS
Receiver
Receivertype
6
Receiverorganization
FDA
Patient
Patientonsetage
59
Patientonsetageunit
801
Patientagegroup
5
Patientsex
2
Reaction
  1. Reactionmeddraversionpt
    29.0
    Reactionmeddrapt
    Ovarian cancer
    Reactionoutcome
    6
Drug
  1. Drugcharacterization
    1
    Medicinalproduct
    BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM
    Drugauthorizationnumb
    212122
    Drugseparatedosagenumb
    1
    Drugdosagetext
    UNK
    Drugadministrationroute
    065
    Actiondrug
    5
    Drugrecurreadministration
    3
    Drugadditional
    3
    Activesubstance
    Activesubstancename
    BUDESONIDE\FORMOTEROL\GLYCOPYRRONIUM
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.